Good manufacturing practice (GMP)

The acronym GMP is used internationally to describe a set of principles and procedures which, when followed by manufacturers of therapeutic goods, helps ensure that the products manufactured will have the required quality. A basic tenet of GMP is that quality cannot be tested into a batch of product but must be built into each batch of product during all stages of the manufacturing process.

Compliance with the Codes of GMP and / or Quality System requirements is ascertained by carrying out regular on-site audits. The purpose of the audits is to assess compliance with the relevant manufacturing standard, the conditions specified in the manufacturing license and compliance with the relevant marketing authorizations. Each audit involves a detailed examination of the operations and procedures of the factory, and includes a detailed review of all processing activities, process validation, batch documentation and quality control testing. Product samples may be taken for testing by relevant authority. The audit is concluded with an exit interview during which the manufacturer is provided with a summary of the findings of the audit. This summary is confirmed in writing at a later date by means of an audit report. The manufacturer is required to respond satisfactorily to the audit report before the audit is closed out.

Where critical and / or several major deficiencies have been found to warrant 'unacceptable' compliance rating, the certification may be suspended or revoked, or some additional conditions imposed on the license if there is a possibility of sub-standard and / or unsafe products being manufactured.